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MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)

NCT04367077 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2021-09-09

No results posted yet for this study

Summary

Multicenter investigation featuring an open-label lead-in followed by a double blinded, randomized, placebo-controlled Phase 2/3 part to evaluate the safety and efficacy of MultiStem therapy in subjects with moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to pathogens including COVID-19.

Conditions

  • ARDS

Interventions

BIOLOGICAL

MultiStem

intravenous infusion

BIOLOGICAL

Placebo

intravenous infusion

Sponsors & Collaborators

  • Healios K.K.

    lead INDUSTRY

Principal Investigators

  • Eric Jenkins, MD · Healios K.K.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-28
Primary Completion
2023-01-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04367077 on ClinicalTrials.gov